In-use stability of enrofloxacin solution for injection in multi-dose containers

The in-use stability study in this paper was designed as far as
possible to simulate the practical usage of multi-dose containers
products in veterinary practice and to establish the influence of storage
conditions on drug's quality. According to literature data, shelf-live of
enrofloxacin solutions for injection tested in this study is 28 days after
opening. In-use (open container) stability testing of enrofloxacin
injection solutions was studied during a period of 112 days, and the
physical-chemical parameters and microbiological contamination were
assessed. A spectrophotometric method was validated for the
quantification of enrofloxacin. The validation method yielded good
results and included the selectivity, linearity, intra-assay precision
(1.26% RSD), inter-assay precision (1.52% RSD), limit of detection
(0.18 g/mL), limit of quantification (0.54 g/mL) and accuracy. The
results of spectrophotometric analyses were presented as the mean
drug concentration of enrofloxacin vs. time of sampling. The findings of
physical, chemical and microbiological parameters were in
accordance with the producers' specifications and no extreme
changes during prescribed storage occurred. The study was extended
from the drug's proposed shelf-life after opening for the next 84 days
and in that period no significant changes were recorded.